Long­time R&D chief Bischof­berg­er leaves Gilead; No­var­tis op­er­a­tions chief heads out; Astel­las taps Bar­ret­to-Ko to run Amer­i­c­as op­er­a­tions

Nor­bert Bischof­berg­er

→ Af­ter a stretch of close to 30 years at Gilead $GILD, long­time R&D chief Nor­bert Bischof­berg­er is leav­ing the com­pa­ny. He’ll be step­ping out at the end of April, the lat­est in a whirl­wind se­ries of changes among the top sci­en­tists in bio­phar­ma. Tak­ing his place will be John McHutchi­son, the cur­rent EVP of clin­i­cal re­search at Gilead. An­drew Cheng is step­ping up as chief med­ical of­fi­cer. Both will re­port di­rect­ly to CEO John Mil­li­gan. The change up comes af­ter a stretch of tu­mul­tuous in­no­va­tion at Gilead; but Bischof­berg­er, who helped ush­er out 25 com­pounds at Gilead, will have no trou­ble mov­ing along in this boom­ing biotech in­dus­try what­ev­er he de­cides to do next.

No­var­tis $NVS is bid­ding farewell to a se­nior Swiss ex­ec, whose de­par­ture has trig­gered some re­struc­tur­ing and sev­er­al pro­mo­tions. An­dré Wyss, cur­rent­ly pres­i­dent of No­var­tis Op­er­a­tions and coun­try pres­i­dent for Switzer­land, has de­cid­ed to step down to “start a new chap­ter in his ca­reer.” With op­er­a­tions be­ing split in­to two de­part­ments, his du­ties will be di­vid­ed be­tween three peo­ple: Matthias Leuen­berg­er takes over the coun­try pres­i­den­cy for Switzer­land; Stef­fen Lang as­sumes the role of glob­al head, No­var­tis Tech­ni­cal Op­er­a­tions; cor­po­rate af­fairs head Philippe Bar­rois leads the busi­ness ser­vices unit un­til the com­pa­ny iden­ti­fies a per­ma­nent suc­ces­sor. Re­flect­ing CEO Vas Narasimhan’s new pri­or­i­ties, No­var­tis has al­so ex­pand­ed San­doz gen­er­al coun­sel Shan­non Klinger’s role to chief ethics, risk and com­pli­ance of­fi­cer, and el­e­vat­ed her, tech­ni­cal op­er­a­tions head Lang, and chief dig­i­tal of­fi­cer Bertrand Bod­son to the ex­ec­u­tive com­mit­tee. In a state­ment, Narasimhan paid trib­ute to Wyss’ long his­to­ry with the com­pa­ny and re­it­er­at­ed his pri­or­i­ties on dig­i­tal tech­nolo­gies and op­er­a­tion ex­e­cu­tion.

→ Over a pe­ri­od of 10 years, An­drew Wit­ty made his rep­u­ta­tion sell­ing drugs around the world as CEO of Lon­don-based Glax­o­SmithK­line. Now, a year af­ter his re­tire­ment, he’s tak­ing the helm of Unit­ed­Health’s gi­ant Op­tum di­vi­sion, one of the largest, fastest grow­ing out­fits in the US which cov­ers phar­ma­cy ben­e­fit man­age­ment and health­care an­a­lyt­ics. Sir An­drew made a rep for him­self by push­ing hard on pa­tient ac­cess to drugs, which led the com­pa­ny to cut prices for poor coun­tries. Now, in­stead of talk­ing about drug pric­ing and ac­cess from a man­u­fac­tur­er’s per­spec­tive, he’ll play a key role in mold­ing re­al-world prac­tices for the world’s biggest drug mar­ket.

June Al­menoff

June Al­menoff had an in­tense four-year run at Fu­riex Phar­ma­ceu­ti­cals, a biotech even­tu­al­ly ac­quired by Ac­tavis (now Al­ler­gan), over­see­ing cor­po­rate and clin­i­cal gov­er­nance. Her new em­ploy­ers at In­no­vate Bio­phar­ma­ceu­ti­cals $IN­NT want her to do it again as their COO and CMO. Like Fu­riex, In­no­vate has a fo­cus on gas­troin­testi­nal ther­a­peu­tics, with a pipeline led by INN-202 (lara­zotide ac­etate) for celi­ac dis­ease. Al­menoff has stayed in­volved in the field since leav­ing Fu­riex in 2014, chair­ing the board of GI biotech RDD Phar­ma and ad­vis­ing oth­er com­pa­nies as a con­sul­tant or a board di­rec­tor. Be­fore jump­ing in­to biotech, she spent 12 years work­ing on busi­ness de­vel­op­ment and clin­i­cal safe­ty at Glax­o­SmithK­line — an ex­pe­ri­ence that al­so en­ticed In­no­vate, which is look­ing to ex­pand in­to more in­di­ca­tions in­clud­ing NASH, in­flam­ma­to­ry bow­el dis­eases and ir­ri­ta­ble bow­el syn­drome.

Per­ci­val Bar­ret­to-Ko

→ Hav­ing over­seen Astel­las’ op­er­a­tions out­side the US for a few years, Per­ci­val Bar­ret­to-Ko has been ap­point­ed to the pres­i­dent’s seat at the com­pa­ny’s Amer­i­c­as di­vi­sion. He will be based out of the cor­po­rate head­quar­ters at North­brook, IL, with re­spon­si­bil­i­ties span­ning in North and South Amer­i­ca. He suc­ceeds his for­mer boss Jim Robin­son, who left ear­li­er this month to be­come pres­i­dent and COO of Alk­er­mes. Bar­rett-Ko first joined Astel­las’ Eu­ro­pean di­vi­sion in 2005, af­ter spend­ing some time at Roche’s US and UK of­fices.

→ In a se­ries of changes among se­nior lead­er­ship, Cana­da’s Xenon Phar­ma­ceu­ti­cals has tapped big phar­ma vet Ernesto Ay­car­di as its CMO. A neu­rol­o­gist by train­ing, Ay­car­di has worked for Bio­gen and Mer­ck KGaA be­fore be­com­ing a VP at Te­va. He will now take over some clin­i­cal re­spon­si­bil­i­ties from Paul Gold­berg, Xenon’s SVP of clin­i­cal de­vel­op­ment, who’s leav­ing the com­pa­ny. Mean­while, CFO Ian Mor­timer will serve the ad­di­tion­al role of pres­i­dent, and Robin Sher­ring­ton has been pro­mot­ed to ex­ec­u­tive vice pres­i­dent of busi­ness and cor­po­rate de­vel­op­ment.

→ Just ahead of an­nounc­ing its $94 mil­lion B round, Ideaya Bio­sciences ap­point­ed Julie Ham­ble­ton as its CMO, head of de­vel­op­ment and SVP. The South San Fran­cis­co biotech is still in pre­clin­i­cal stages, but the team hopes that Ham­ble­ton’s ex­pe­ri­ence in mar­ket­ing fil­ings, reg­u­la­to­ry af­fairs and post-launch stud­ies will some­day come in­to use. Be­tween Bris­tol-My­ers Squibb, Clo­vis On­col­o­gy and Genen­tech, Ham­ble­ton has learned a thing or two about im­muno-on­col­o­gy, which she will now lever­age to ad­vance Ideaya’s syn­thet­ic lethal­i­ty meds.

→ Af­ter co-found­ing Goldfinch BioThird Rock Ven­tures’ Pe­ter Mundel has tak­en on a more hands-on role as CSO of the Cam­bridge, MA biotech. Hav­ing de­vot­ed much of his re­search ca­reer to find­ing pre­ci­sion ther­a­pies for kid­ney dis­eases, Mundel had shut down his lab at Har­vard Med­ical School to pur­sue ge­net­ic-based treat­ments of kid­ney dis­eases. In the same state­ment, the com­pa­ny an­nounced it has ap­point­ed health care ser­vice pro­fes­sion­al Frank Mad­dux to the board.

Mer­sana $MRSN has scooped an ex­pe­ri­enced Ver­tex fi­nance ex­ec to be its new CFO. David Spell­man, who rose to VP of cor­po­rate, com­mer­cial and in­ter­na­tion­al fi­nance af­ter 12 years at Ver­tex, is step­ping in as the biotech builds up its struc­ture in prepa­ra­tion for lat­er stage clin­i­cal de­vel­op­ment. A for­mer mem­ber of the team at Mil­len­ni­um Phar­ma­ceu­ti­cals that launched Vel­cade, Spell­man said he’s at­tract­ed to the pro­duc­tiv­i­ty of Mer­sana’s team in de­vel­op­ing its an­ti­body-drug con­ju­gate on­col­o­gy pipeline.

→ San Diego-based Il­lu­mi­na $ILMN has tapped Phil Feb­bo as its next CMO, where the for­mer UCSF pro­fes­sor will steer the com­pa­ny’s strat­e­gy to bring ge­nom­ic test­ing in­to health care prac­tice. Feb­bo de­buted his biotech ca­reer at Ge­nom­ic Health, a com­pa­ny ded­i­cat­ed to can­cer de­tec­tion, not un­like Il­lu­mi­na’s high pro­file spin­out Grail.

→ Af­ter a ca­reer at big phar­ma, Aled Williams is adding a biotech job to his re­sume. The CCO and head of pa­tient ac­cess role at Ther­a­chon makes sense giv­en its fo­cus on rare dis­eases, a field that Williams has had plen­ty of time to ex­plore dur­ing the past eight years at Shire. Be­fore that, he’s spent some time man­ag­ing brand and prod­ucts across Bris­tol-My­ers Squibb, No­var­tis and Roche. The biotech — lo­cat­ed in Basel, Switzer­land — is look­ing to form part­ner­ships for its lead prod­uct can­di­date, which treats a com­mon form of short-limb dwarfism.

→ CAR-T up­start Mus­tang Bio has pro­mot­ed two of its ear­li­est staffers to the C-suite. Sadik Kas­sim, pre­vi­ous­ly VP of process and an­a­lyt­i­cal de­vel­op­ment, is now the CSO; Knut Niss, who joined last year as VP of op­er­a­tions, will take the chief tech­nol­o­gy of­fi­cer ti­tle. Both Kas­sim and Niss were in­volved with No­var­tis’ Kym­ri­ah (in the BLA fil­ing and process trans­fer de­part­ments, re­spec­tive­ly) — an ex­pe­ri­ence shared with Mus­tang CEO Man­ny Litch­man. Dis­tin­guish­ing it­self on both the sci­ence and man­u­fac­tur­ing front will be cru­cial for the New York biotech to claim a place in this field, some­thing that the team is clear­ly keen to do.

→ In­vest­ment banker Joseph Fer­ra is the new CFO at Sy­ros $SYRS, where read­outs of the two most ad­vanced pro­grams, based on its gene con­trol plat­form and tar­get­ing can­cer and mono­genic dis­eases, are ex­pect­ed this year. The out­comes of those tri­als will be crit­i­cal if Sy­ros is to bounce back from the in­vestor back­lash at the Amer­i­can So­ci­ety of Hema­tol­ogy meet­ing late last year.

→ With busi­ness de­vel­op­ment head Christophe Jean’s re­tire­ment, Paris-based Ipsen has brought in Ivana Magov­če­vić-Liebisch to nav­i­gate the next phase of its part­ner­ing strate­gies as CBO and EVP. Magov­če­vić-Liebisch held a brief stint at Ax­cel­la Health af­ter leav­ing Te­va, and be­fore that had been a long­time COO of Dyax. Her ap­point­ment co­in­cides with that of Régis Mu­lot, the new chief hu­man re­sources of­fi­cer com­ing from the re­tail sec­tor.

Five Prime Ther­a­peu­tics $FPRX is search­ing for a new CFO as Marc Bel­sky, the long­time ex­ec who saw the com­pa­ny through a $62 mil­lion IPO and sub­se­quent fi­nanc­ings, has de­cid­ed to leave.

→ Now that As­sem­bly Bio­sciences $ASMB has run steadi­ly as a pub­lic com­pa­ny for a while, co-founder David Bar­rett is pass­ing the CFO and COO ba­ton to Gra­ham Coop­er. For­mer­ly the CFO at Re­cep­tos, Coop­er takes over a com­pa­ny that’s most­ly still fo­cused on pre­clin­i­cal stud­ies in HBV and mi­cro­bio­me, a few of which Al­ler­gan has part­nered on. Mean­while, ex-Kite Phar­ma ex­ec He­len Kim has joined the board, of­fer­ing strate­gic guid­ance like Bar­rett — who re­mains as a strate­gic ad­vis­er — will.

John Hohnek­er is keep­ing busy out­side of his day job at Anokion, tak­ing a board seat at next-gen im­muno-on­col­o­gy start­up Torque just a cou­ple of months af­ter he start­ed as Anokion’s CEO. The bio­phar­ma vet said he’s drawn to the po­ten­tial of Torque’s tech plat­form which can con­trol im­mune ac­ti­va­tion “deep in tu­mors.” Al­so join­ing as a di­rec­tor is Har­vard med pro­fes­sor Marcela Maus, an ex­pert in T cell im­munother­a­pies.

Eli Lil­ly has re­cruit­ed Memo­r­i­al Sloan Ket­ter­ing breast can­cer re­searcher Mau­ra Dick­ler to lead late phase de­vel­op­ment as VP in its on­col­o­gy group.

→ Look­ing to ex­pand its client base in Eu­rope, Cam­bridge, UK-based drug dis­cov­ery ser­vice provider Do­mainex has ap­point­ed Bo­do Spori as head of busi­ness de­vel­op­ment for Eu­rope. The ex­ecs like the sales work he did at Cypro­tex, a sub­sidiary of Evotec, and are trust­ing him to build re­la­tion­ships with bio­phar­ma com­pa­nies across the con­ti­nent.

→ As Fre­quen­cy Ther­a­peu­tics preps its lead hear­ing restora­tion pro­gram for Phase II tri­als lat­er this year, it is en­list­ing the help of Carl LeBel, its new EVP of clin­i­cal de­vel­op­ment. An Am­gen vet, LeBel has tak­en a short break from the front lines since leav­ing the CSO po­si­tion at Oton­o­my, par­tic­i­pat­ing in­stead as a con­sul­tant. He will now be di­rect­ly in­volved in Fre­quen­cy’s re­gen­er­a­tive plat­form known as prog­en­i­tor cell ac­ti­va­tion.

John Mo­ri­ar­ty has left Alex­ion to be­come EVP and gen­er­al coun­sel at Por­to­la Phar­ma­ceu­ti­cals $PT­LA, as the South San Fran­cis­co biotech con­tin­ues its tran­si­tion in­to a com­mer­cial op­er­a­tion fol­low­ing the launch of its first FDA-ap­proved ther­a­py. As chief le­gal of­fi­cer, he will keep an eye on all things le­gal, reg­u­la­to­ry, and gov­er­nance- or com­pli­ance-re­lat­ed. He will al­so have a role to play in busi­ness trans­ac­tions and cor­po­rate ex­pan­sion.

Ac­tini­um Phar­ma $AT­NM is en­trust­ing the fate of its pipeline of an­ti­body ra­dio-con­ju­gate based drug can­di­dates to Je­han Row­lands, its new VP, head of reg­u­la­to­ry af­fairs. The New York biotech in­tends to keep his hands full with first the BLA fil­ing for Iomab-B, Ac­tini­um’s lead mye­loab­la­tion drug cur­rent­ly in a piv­otal Phase III tri­al, and many more fu­ture clin­i­cal tri­als for blood can­cer ra­dioim­munother­a­pies. Row­lands has a pen­chant for work­ing at com­pa­nies that even­tu­al­ly get ac­quired, from For­est Lab­o­ra­to­ries (Al­ler­gan), NPS Phar­ma (Shire) to In­faCare (Mallinck­rodt), earn­ing him ex­pe­ri­ence in mul­ti­ple ther­a­peu­tic ar­eas along the way.

→ Neoanti­gen can­cer vac­cine de­vel­op­er Geno­cea $GN­CA has poached Am­gen vet Narinder Singh as SVP of phar­ma­ceu­ti­cal sci­ences and man­u­fac­tur­ing. Com­ing di­rect­ly from out­sourc­ing com­pa­ny Mo­men­ta, Singh’s ini­tial fo­cus will be GEN-009, the pre­clin­i­cal can­di­date moved up to lead sta­tus af­ter the Cam­bridge, MA biotech shelved its her­pes treat­ment. Phase I tri­als are slat­ed for this year.

Astel­las is shak­ing up its le­gal and hu­man re­sources teams with a string of pro­mo­tions. Rod­er­ick Christ­mon is now ex­ec­u­tive di­rec­tor, med­ical & de­vel­op­ment, pre­sum­ably with broad­er au­thor­i­ty to man­age and re­tain tal­ent. In the le­gal de­part­ment, Matt Sil­ver­stein will head lit­i­ga­tion and in­ves­ti­ga­tions while Bri­an Tay­lor over­sees busi­ness de­vel­op­ment/al­liance man­age­ment, pro­vid­ing le­gal sup­port for com­plex trans­ac­tions.

→ As AGC Bi­o­log­ics in­creas­es its pres­ence in the con­tract de­vel­op­ment and man­u­fac­tur­ing world, it has in­stalled new VPs of busi­ness de­vel­op­ment in both North Amer­i­ca and Eu­rope. Ax­el Schley­er, most re­cent­ly of Boehringer In­gel­heim, will stay on the Amer­i­can side while Rentschler Biotech­nolo­gie alum Christoph Win­ter­hal­ter man­ages Eu­ro­pean clients.

→ Cana­da’s In­Med — a mem­ber of the bur­geon­ing field of cannabi­noid-based drug de­vel­op­ers — has named Er­ic Hsu VP of pre­clin­i­cal re­search and de­vel­op­ment. Hsu, who moved from a sim­i­lar po­si­tion at en­Gene, will take charge of the com­pa­ny’s biosyn­the­sis man­u­fac­tur­ing process and ear­ly-stage re­search on drug can­di­dates, in­clud­ing prod­ucts for glau­co­ma and pain.

→ Hav­ing ad­vised Epizyme’s epi­ge­net­ic ther­a­pies for sev­er­al months, Michael Gior­dano — Bris­tol-My­ers Squibb’s for­mer head on­col­o­gy and im­muno-on­col­o­gy of Op­di­vo and Yer­voy fame — has of­fi­cial­ly joined the board of di­rec­tors. The Cam­bridge, MA-based biotech is de­vel­op­ing epi­ge­net­ic med­i­cines tar­get­ing a range of dis­eases in­clud­ing can­cer and sick­le cell dis­ease.

→ Toron­to-based Scythi­an Bio­sciences has named Vic Neufeld the new chair­man of its board of di­rec­tors, re­liev­ing CEO Jonathan Gilbert of the du­ties. Neufeld is a rel­a­tive­ly new di­rec­tor hav­ing joined just two months ago, but as CEO of an­oth­er cannabi­noid com­pa­ny he’s had some ex­po­sure to the field.

Robert Sav­age, who claims the world­wide chair­man­ship of J&J’s phar­ma group as one of his many for­mer ti­tles, has joined Hu­mani­gen’s board. Sav­age said he’s most in­ter­est­ed in help­ing with the “long-term hu­man strat­e­gy” in push­ing to make CAR-T safer.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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